Functional electrical stimulation during walking in children with unilateral spastic cerebral palsy: A randomized cross-over trial.

AIM: To study if functional electrical stimulation (FES) of the peroneal nerve, which activates dorsiflexion, can improve body functions, activities, and participation and could be an effective alternative treatment in individuals with unilateral spastic cerebral palsy (CP). METHOD: A randomized cross-over trial was performed in 25 children with unilateral spastic CP (classified in Gross Motor Function Classification System levels I and II) aged 4 to 18 years (median age at inclusion 9 years 8 months, interquartile range = 7 years-13 years 8 months), 15 patients were male. The study consisted of two 12-week blocks of treatment, that is, conventional treatment (ankle foot orthosis [AFO] or adapted shoes) and FES, separated by a 6-week washout period. Outcome measures included the Goal Attainment Scale (GAS), the Cerebral Palsy Quality of Life questionnaire, and a three-dimensional gait analysis. RESULTS: Eighteen patients completed the trial. The proportion of GAS goals achieved was not significantly higher in the FES versus the conventional treatment phase (goal 1 p = 0.065; goal 2 p = 1.00). When walking while stimulated with FES, ankle dorsiflexion during mid-swing decreased over time (p = 0.006, average decrease of 4.8° with FES), with a preserved increased ankle range of motion compared to conventional treatment (p < 0.001, mean range of motion with FES +10.1° compared to AFO). No changes were found in the standard physical examination or regarding satisfaction with orthoses and feelings about the ability to dress yourself. In four patients, FES therapy failed; in 12 patients FES therapy continued after the trial. INTERPRETATION: FES is not significantly worse than AFO; however, patient selection is critical, and a testing period and thorough follow-up are needed.

Changes in running economy and running technique following 6 months of running with and without wearable-based real-time feedback.

BACKGROUND: An increasing number of commercially available wearables provide real-time feedback on running biomechanics with the aim to reduce injury risk or improve performance. OBJECTIVE: Investigate whether real-time feedback by wearable insoles (ARION) alters running biomechanics and improves running economy more as compared to unsupervised running training. We also explored the correlation between changes in running biomechanics and running economy. METHODS: Forty recreational runners were randomized to an intervention and control group and performed ~6 months of in-field training with or without wearable-based real-time feedback on running technique and speed. Running economy and running biomechanics were measured in lab conditions without feedback pre and post intervention at four speeds. RESULTS: Twenty-two individuals (13 control, 9 intervention) completed both tests. Both groups significantly reduced their energetic cost by an average of -6.1% and -7.7% for the control and intervention groups, respectively. The reduction in energy cost did not significantly differ between groups overall (-0.07 ± 0.14 J∙kg∙m-1 , -1.5%, p = 0.63). There were significant changes in spatiotemporal metrics, but their magnitude was minor and did not differ between the groups. There were no significant changes in running kinematics within or between groups. However, alterations in running biomechanics beyond typical session-to-session variation were observed during some in-field sessions for individuals that received real-time feedback. CONCLUSION: Alterations in running biomechanics as observed during some in-field sessions for individuals receiving wearable-based real-time feedback did not result in significant differences in running economy or running biomechanics when measured in controlled lab conditions without feedback.

Operationalizing and digitizing person-centered daily functioning: a case for functionomics.

An ever-increasing amount of data on a person's daily functioning is being collected, which holds information to revolutionize person-centered healthcare. However, the full potential of data on daily functioning cannot yet be exploited as it is mostly stored in an unstructured and inaccessible manner. The integration of these data, and thereby expedited knowledge discovery, is possible by the introduction of functionomics as a complementary 'omics' initiative, embracing the advances in data science. Functionomics is the study of high-throughput data on a person's daily functioning, that can be operationalized with the International Classification of Functioning, Disability and Health (ICF).A prerequisite for making functionomics operational are the FAIR (Findable, Accessible, Interoperable, and Reusable) principles. This paper illustrates a step by step application of the FAIR principles for making functionomics data machine readable and accessible, under strictly certified conditions, in a practical example. Establishing more FAIR functionomics data repositories, analyzed using a federated data infrastructure, enables new knowledge generation to improve health and person-centered healthcare. Together, as one allied health and healthcare research community, we need to consider to take up the here proposed methods.

The effectiveness of a protocol without routine radiographs for follow-up of adolescent idiopathic scoliosis patients (CURVE): a study protocol.

BACKGROUND AND PURPOSE: Current follow-up protocols for adolescent idiopathic scoliosis (AIS) are based on consensus and consist of regular full-spine radiographs to monitor curve progression and surgical complications. Consensus exists to avoid inappropriate use of radiographs in children. It is unknown whether a standard radiologic follow-up (S-FU) approach is necessary or if a patient-empowered follow-up (PE-FU) approach can reduce the number of radiographs without treatment consequences. METHODS AND ANALYSES: A nationwide multicenter pragmatic randomized preference trial was designed for 3 follow-up subgroups (pre-treatment, post-brace, post-surgery) to compare PE-FU and S-FU. 812 patients with AIS (age 10-18 years) will be included in the randomized trial or preference cohorts. Primary outcome is the proportion of radiographs with a treatment consequence for each subgroup. Secondary outcomes consist of the proportion of patients with delayed initiation of treatment due to non-routine radiographic follow-up, radiation exposure, societal costs, positive predictive value, and interrelation of clinical assessment, quality of life, and parameters for initiation of treatment during follow-up. Outcomes will be analyzed using linear mixed-effects models, adjusted for relevant baseline covariates, and are based on intention-to-treat principle. Study summary: (i) a national, multicenter pragmatic randomized trial addressing the optimal frequency of radiographic follow-up in patients with AIS; (ii) first study that includes patient-empowered follow-up; (iii) an inclusive study with 3 follow-up subgroups and few exclusion criteria representative for clinical reality; (iv) preference cohorts alongside to amplify generalizability; (v) first study conducting an economic evaluation comparing both follow-up approaches.

The accuracy of commercially available instrumented insoles (ARION) for measuring spatiotemporal running metrics.

Spatiotemporal metrics such as step frequency have been associated with running injuries in some studies. Wearables can measure these metrics and provide real-time feedback in-field, but are often not validated. This study assessed the validity of commercially available wireless instrumented insoles (ARION) for quantifying spatiotemporal metrics during level running at different speeds (2.78-5.0 m s-1 ,) and slopes (3° and 6° up/downhill) to an instrumented treadmill. Mean raw, percentage and absolute percentage error, and limits of agreement (LoA) were calculated. Agreement was statistically quantified using four thresholds: excellent, <5%; good, <10%; acceptable, <15%; and poor, >15% error. Excellent agreement (<5% error) was achieved for stride time across all conditions, and for step frequency across all but one condition with good agreement. Contact time and swing time generally showed at least good agreement. The mean difference across all conditions was -0.95% for contact time, 0.11% for stride time, 0.6% for swing time, -0.11% for step frequency, and -0.09% when averaged across all outcomes and conditions. The accuracy at an individual level was generally good to excellent, being <10% for all but two conditions, with these conditions being <15%. Additional experiments among four runners showed that step length could also be measured with an accuracy of 1.76% across different speeds with an updated version of the insoles. These findings suggests that the ARION wearable may not only be useful for large-scale in-field studies investigating group differences, but also to quantify spatiotemporal metrics with generally good to excellent accuracy for individual runners.

Predictors of poor outcome following lumbar spinal fusion surgery: a prospective observational study to derive two clinical prediction rules using British Spine Registry data.

PURPOSE: Lumbar spinal fusion surgery (LSFS) is common for lumbar degenerative disorders. The objective was to develop clinical prediction rules to identify which patients are likely to have a favourable outcome to inform decisions regarding surgery and rehabilitation. METHODS: A prospective observational study recruited 600 (derivation) and 600 (internal validation) consecutive adult patients undergoing LSFS for degenerative lumbar disorder through the British Spine Registry. Definition of good outcome (6 weeks, 12 months) was reduction in pain intensity (Numerical Rating Scale, 0-10) and disability (Oswestry Disability Index, ODI 0-50) > 1.7 and 14.3, respectively. Linear and logistic regression models were fitted and regression coefficients, Odds ratios and 95% CIs reported. RESULTS: Lower BMI, higher ODI and higher leg pain pre-operatively were predictive of good disability outcome, higher back pain was predictive of good back pain outcome, and no previous surgery and higher leg pain were predictive of good leg pain outcome; all at 6 weeks. Working and higher leg pain were predictive of good ODI and leg pain outcomes, higher back pain was predictive of good back pain outcome, and higher leg pain was predictive of good leg pain outcome at 12 months. Model performance demonstrated reasonable to good calibration and adequate/very good discrimination. CONCLUSIONS: BMI, ODI, leg and back pain and previous surgery are important considerations pre-operatively to inform decisions for surgery. Pre-operative leg and back pain and work status are important considerations to inform decisions for management following surgery. Findings may inform clinical decision making regarding LSFS and associated rehabilitation.

Phase 1 Randomized, Placebo-Controlled, Dose-Escalating Study to Evaluate OVX836, a Nucleoprotein-Based Influenza Vaccine: Intramuscular Results.

BACKGROUND: OVX836 is a recombinant protein vaccine targeting the highly conserved influenza nucleoprotein (NP), which could confer broad-spectrum protection against this disease. METHODS: A randomized, placebo-controlled, double-blind, dose-escalating, single- center, first-in-human study was conducted in 36 healthy adults aged 18-49 years. Twelve subjects per cohort (9 vaccine and 3 placebo) received 2 OVX836 intramuscular administrations on days 1 and 28 at the dose level of 30 µg, 90 µg, or 180 µg. Safety and immunogenicity were assessed after each vaccination and for 150 days in total. RESULTS: OVX836 was safe and well tolerated at all dose levels, with no difference in solicited local and systemic symptoms, and unsolicited adverse events between the first and second administration, or between dose levels. All subjects presented pre-existing NP-specific immunity at baseline. OVX836 induced a significant increase in NP-specific interferon-gamma T cells and anti-NP immunoglobulin G at all dose levels after the first vaccination. The second vaccination did not further increase the response. There was a trend for a dose effect in the immune response. CONCLUSIONS: The safety and reactogenicity profile, as well as the humoral and cellular immune responses, encourage further evaluation of OVX836 in a larger Phase 2a study.

Local bone metabolism during the consolidation process of spinal interbody fusion.

INTRODUCTION: Although computed tomography (CT) can identify the presence of eventual bony bridges following lumbar interbody fusion (LIF) surgery, it does not provide information on the ongoing formation process of new bony structures. 18F sodium fluoride (18F-NaF) positron emission tomography (PET) could be used as complementary modality to add information on the bone metabolism at the fusion site. However, it remains unknown how bone metabolism in the operated segment changes early after surgery in uncompromised situations. This study aimed to quantify the changes in local bone metabolism during consolidation of LIF. MATERIALS AND METHODS: Six skeletally mature sheep underwent LIF surgery. 18F-NaF PET/CT scanning was performed 6 and 12 weeks postoperatively to quantify the bone volume and metabolism in the operated segment. Bone metabolism was expressed as a function of bone volume. RESULTS: Early in the fusion process, bone metabolism was increased at the endplates of the operated vertebrae. In a next phase, bone metabolism increased in the center of the interbody region, peaked, and declined to an equilibrium state. During the entire postoperative time period of 12 weeks, bone metabolism in the interbody region was higher than that of a reference site in the spinal column. CONCLUSION: Following LIF surgery, there is a rapid increase in bone metabolism at the vertebral endplates that develops towards the center of the interbody region. Knowing the local bone metabolism during uncompromised consolidation of spinal interbody fusion might enable identification of impaired bone formation early after LIF surgery using 18F-NaF PET/CT scanning.

Muscle forces and fascicle behavior during three hamstring exercises.

Knowledge about muscular forces and fascicle behavior during hamstring exercises can optimize exercise prescription, but information on these outcomes across different exercises is lacking. We aimed to characterize and compare lower-limb muscle forces and biceps femoris long head muscle fascicle behavior between three hamstring exercises: the Nordic hamstring curl (NHC), single-leg Roman chair (RCH), and single-leg deadlift (DL). Ten male participants performed the exercises while full-body kinematics, ground reaction forces, surface muscle activation, and biceps femoris long head fascicle behavior were measured. Mean fascicle length was highest in the DL, followed by the RCH and NHC. Fascicle lengthening was higher in the NHC compared with the RCH and DL, with no difference between the RCH and DL. Biceps femoris short and long head, semitendinosus, and semimembranosus peak forces were generally higher in the NHC compared with the RCH and DL, while mean forces during the eccentric phase were generally not different between the NHC and RCH. Peak forces in the NHC coincided with low biceps femoris long head and semimembranosus muscle activation. The NHC generally has the highest peak hamstring muscle forces and results in more fascicle lengthening when compared to the DL and RCH. The NHC may therefore be most effective to promote increases in fascicle length. While the NHC may be effective to promote biceps femoris short head and semitendinosus strength adaptations, the RCH and DL may be more effective to promote strength increases in the biceps femoris long head and semimembranosus.

A randomized crossover study of functional electrical stimulation during walking in spastic cerebral palsy: the FES on participation (FESPa) trial.

BACKGROUND: Spastic cerebral palsy is the most common cause of motor disability in children. It often leads to foot drop or equinus, interfering with walking. Ankle-foot orthoses (AFOs) are commonly used in these cases. However, AFOs can be too restrictive for mildly impaired patients. Functional electrical stimulation (FES) of the ankle-dorsiflexors is an alternative treatment as it could function as a dynamic functional orthosis. Despite previous research, high level evidence on the effects of FES on activities and participation in daily life is missing. The primary aim of this study is to evaluate whether FES improves the activity and participation level in daily life according to patients, and the secondary aim is to provide evidence of the effect of FES at the level of body functions and activities. Furthermore, we aim to collect relevant information for decisions on its clinical implementation. METHODS: A randomized crossover trial will be performed on 25 children with unilateral spastic cerebral palsy. Patients aged between 4 and 18 years, with Gross Motor Functioning Classification System level I or II and unilateral foot drop of central origin, currently treated with AFO or adapted shoes, will be included. All participants will undergo twelve weeks of conventional treatment (AFO/adapted shoes) and 12 weeks of FES treatment, separated by a six-week washout-phase. FES treatment consists of wearing the WalkAide® device, with surface electrodes stimulating the peroneal nerve during swing phase of gait. For the primary objective, the Goal Attainment Scale is used to test whether FES improves activities and participation in daily life. The secondary objective is to prove whether FES is effective at the level of body functions and structures, and activities, including ankle kinematics and kinetics measured during 3D-gait analysis and questionnaire-based frequency of falling. The tertiary objective is to collect relevant information for clinical implementation, including acceptability using the device log file and side effect registration, cost-effectiveness based on quality adjusted life years (QALYs) and clinical characteristics for patient selection. DISCUSSION: We anticipate that the results of this study will allow evidence-based use of FES during walking in children with unilateral spastic cerebral palsy. TRIAL REGISTRATION: ClinicalTrials.gov : NCT03440632 .

Immediate patient perceptions following lumbar spinal fusion surgery: semi-structured multi-centre interviews exploring the patient journey and experiences of lumbar fusion surgery (FuJourn).

PURPOSE: To understand the patient journey to Lumbar Spinal Fusion Surgery (LSFS) and patients' experiences of surgery. METHODS: Qualitative study using interpretive phenomenological analysis. Adult participants following LSFS were recruited from 4 UK clinical sites using purposive sampling to ensure representation of key features (e.g. age). Semi-structured interviews informed by a piloted topic guide developed from the literature were audio-recorded and transcribed verbatim. Framework analysis for individual interviews and then across participants (deductive and inductive) identified emerging themes. Trustworthiness of data analyses was enhanced using multiple strategies (e.g. attention to negative cases). RESULTS: Four emerging themes from n = 31 patients' narratives were identified: decision for surgery, coping strategies, barriers to recovery and recovery after surgery. Decision for surgery and recovery after surgery themes are distinguished by the point of surgery. However, barriers to recovery and coping strategies are key to the whole patient journey encompassing long journeys to surgery and their initial journey after surgery. The themes of coping strategies and barriers to recovery were inter-related and perceived by participants as parallel concepts. The 4 multifactorial themes interacted with each other and shaped the process of an individual patient's recovery. Factors such as sporadic interventions prior to surgery, time-consuming wait for diagnosis and surgery and lack of information regarding recovery strongly influenced perceptions of outcome. CONCLUSION: Patient driven data enables insights to inform research regarding surgery/rehabilitation through depth of understanding of the patient journey. Awareness of factors important to patients is important; ensuring that patient-driven data informs research and patient care.

Gait analysis and clinical outcome in patients after pilon fracture surgery.

BACKGROUND: In this study kinematic parameters, radiographic findings and PROM in pilon fractures after operative treatment were compared with healthy subjects. METHODS: 16 patients treated with osteosynthesis after pilon fracture underwent kinematic analysis with the OFM. Fractures were evaluated for post-operative step-off and gap on CT-scans and PROM were collected. Results were compared to 10 healthy persons. RESULTS: Range of motion (ROM) crural was lower in the flexion/extension for pilon fractures (10.03 vs. 13.15, p = 0.017). The ROM in the inversion/eversion was low, but ROM in the abduction/adduction was higher. Correlations were found between flexion/extension and AO-classification (r = -0.357 p < 0.05), PROM score of the AOFAS (r = 0.445 p < 0.01), post-operative gap and step-off in the tibia plafond. CONCLUSION: Pilon fractures showed decreased ROM between the hindfoot and tibia in the sagittal and transverse plane, but increased ROM in the frontal plane during push-off phase as compensatory kinetics. ROM showed significant correlations with PROM and intra-articular step-off and gap in the tibia plafond.

Exploring Associations of Preoperative Physical Performance With Postoperative Outcomes After Lumbar Spinal Fusion: A Machine Learning Approach.

OBJECTIVE: To explore the association between preoperative physical performance with short- and long-term postoperative outcomes in patients undergoing lumbar spinal fusion (LSF). DESIGN: Retrospective cohort. SETTING: University hospital. PARTICIPANTS: Seventy-seven patients (N=77) undergoing elective LSF were preoperatively screened on patient demographics, patient-reported outcome measures, and physical performance measures (movement control, back muscle endurance strength and extensor strength, aerobic capacity, flexibility). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Associations between preoperative variables and inpatient functional recovery, hospital length of stay (LOS), and 1- to 2-year postoperative pain reduction were explored using random forest analyses assessing the relative influence of the variable on the outcome. RESULTS: Aerobic capacity was associated with fast functional recovery <4 days and prolonged functional recovery >5 days (median z scores=7.1 and 12.0). Flexibility (median z score=4.3) and back muscle endurance strength (median z score=7.8) were associated with fast functional recovery <4 days. Maximum back extensor strength was associated with prolonged functional recovery >5 days (median z score=8.6). Flexibility (median z score=5.1) and back muscle endurance strength (median z score=13.5) were associated with short LOS <5 days. Aerobic capacity (median z score=8.7) was associated with prolonged LOS >7 days. Maximum back extensor strength (median z score=3.8) was associated with 1- to 2-year postoperative pain reduction and aerobic capacity (median z score=2.8) was tentative. CONCLUSIONS: Physical performance measures were associated with both short- and long-term outcomes after LSF. Adding these measures to prediction models predicting outcomes after LSF may increase their accuracy.

International comparative study of low back pain care pathways and analysis of key interventions.

PURPOSE: Low back pain (LBP) is a major public health problem worldwide. Significant practice variation exists despite guidelines, including strong interventionist focus by some practitioners. Translation of guidelines into pathways as integrated treatment plans is a next step to improve implementation. The goal of the present study was to analyze international examples of LBP pathways in order to identify key interventions as building elements for care pathway for LBP and radicular pain. METHODS: International examples of LBP pathways were searched in literature and grey literature. Authors of pathways were invited to fill a questionnaire and to participate in an in-depth telephone interview. Pathways were quantitatively and qualitatively analyzed, to enable the identification of key interventions to serve as pathway building elements. RESULTS: Eleven international LBP care pathways were identified. Regional pathways were strongly organized and included significant training efforts for primary care providers and an intermediate level of caregivers in between general practitioners and hospital specialists. Hospital pathways had a focus on multidisciplinary collaboration and stepwise approach trajectories. Key elements common to all pathways included the consecutive screening for red flags, radicular pain and psychosocial risk factors, the emphasis on patient empowerment and self-management, the development of evidence-based consultable protocols, the focus on a multidisciplinary work mode and the monitoring of patient-reported outcome measures. CONCLUSION: Essential building elements for the construction of LBP care pathways were identified from a transversal analysis of key interventions in a study of 11 international examples of LBP pathways.

Development and validation of a prediction tool for pain reduction in adult patients undergoing elective lumbar spinal fusion: a multicentre cohort study.

PURPOSE: On average, 56% of patients report a clinically relevant reduction in pain after lumbar spinal fusion (LSF). Preoperatively identifying which patient will benefit from LSF is paramount to improve clinical decision making, expectation management and treatment selection. Therefore, this multicentre study aimed to develop and validate a clinical prediction tool for a clinically relevant reduction in pain 1 to 2 years after elective LSF. METHODS: The outcomes were defined as a clinically relevant reduction in predominant (worst reported pain in back or legs) pain 1 to 2 years after LSF. Patient-reported outcome measures and patient characteristics from 202 patients were used to develop a prediction model by logistic regression. Data from 251 patients were used to validate the model. RESULTS: Nonsmokers (odds ratio = 0.41 [95% confidence interval = 0.19-0.87]), with lower Body Mass Index (0.93 [0.85-1.01]), shorter pain duration (0.49 [0.20-1.19]), lower American Society of Anaesthesiologists score (4.82 [1.35-17.25]), higher Visual Analogue Scale score for predominant pain (1.05 [1.02-1.08]), lower Oswestry Disability Index (0.96 [0.93-1.00]) and higher RAND-36 mental component score (1.03 [0.10-1.06]) preoperatively had a higher chance of a clinically relevant reduction in predominant pain. The area under the curve of the externally validated model yielded 0.68. A nomogram was developed to aid clinical decision making. CONCLUSIONS: Using the developed nomogram surgeons can estimate the probability of achieving a clinically relevant pain reduction 1 to 2 years after LSF and consequently inform patients on expected outcomes when considering treatment.

Gait in patients with symptomatic osteoporotic vertebral compression fractures over 6 months of recovery.

BACKGROUND: One factor related to disability in people with spinal deformity is decreased postural control and increased risk of falling. However, little is known about the effect of osteoporotic vertebral compression fractures (OVCFs) and their recovery on gait and stability. Walking characteristics of older adults with and without vertebral fractures have not yet been compared. AIMS: The purpose of the current study was to examine the spatiotemporal gait parameters and their variability in patients with an OVCF and healthy participants during treadmill walking at baseline and after 6 months of recovery. METHODS: Twelve female patients suffering a symptomatic OVCF were compared to 11 matched controls. Gait analysis was performed with a dual-belt instrumented treadmill with a 180° projection screen providing a virtual environment (computer-assisted rehabilitation environment). Results of patients with an OVCF and healthy participants were compared. Furthermore, spatiotemporal gait parameters were assessed over 6 months following the fracture. RESULTS: Patients suffering from an OVCF appeared to walk with significantly shorter, faster and wider strides compared to their healthy counterparts. Although stride time and length improved over time, the majority of the parameters analysed remained unchanged after 6 months of conservative treatment. DISCUSSION: Since patients do not fully recover to their previous level of mobility after 6 months of conservative treatment for OVCF, it appears of high clinical importance to add balance and gait training to the treatment algorithm of OVCFs. CONCLUSIONS: Patients suffering from an OVCF walk with shorter, faster and wider strides compared to their healthy counterparts adopt a less stable body configuration in the anterior direction, potentially increasing their risk of forward falls if perturbed. Although stride time and stride length improve over time even reaching healthy levels again, patients significantly deviate from normal gait patterns (e.g. in stability and step width) after 6 months of conservative treatment.

Correlates of affective empathy, perspective taking, and generativity among a sample of adults.

Previous research suggests that empathy can be cultivated by social ideals and relationships with people. The current study examines family importance and religious importance as correlates of affective empathy, perspective taking, and generativity among a sample of adults aged 18 to 35 (N = 722). Given the ethnic and racial diversity represented by Millennials and Generation Z, the moderating role of racial group membership is explored as well. Results indicate that family importance is positively associated with affective empathy, perspective taking, and generativity for the overall sample, though the relationship is particularly strong for non-Hispanic whites. Religious importance is significantly related to affective empathy and generativity (not perspective taking), primarily among Black, Indigenous, and/or People of Color. Due to the increasing visibility of victimization towards socially vulnerable groups, it is important to understand how attitudes oriented towards helping and empathizing with others are fostered. Implications for further research are discussed.

A prediction model of surgical site infection after instrumented thoracolumbar spine surgery in adults.

PURPOSE: The aim of this study was to develop and internally validate a multivariable model for accurate prediction of surgical site infection (SSI) after instrumented spine surgery using a large cohort of a Western European academic center. METHOD: Data of potential predictor variables were collected in 898 adult patients who underwent instrumented posterior fusion of the thoracolumbar spine. We used logistic regression analysis to develop the prediction model for SSI. The ability to discriminate between those who developed SSI and those who did not was quantified as the area under the receiver operating characteristic curve (AUC). Model calibration was evaluated by visual inspection of the calibration plot and by computing the Hosmer and Lemeshow goodness-of-fit test. RESULTS: Sixty patients (6.7%) were diagnosed with an SSI. After backward stepwise elimination of predictor variables, we formulated a model in which an individual's risk of an SSI can be computed. Age, body mass index, ASA score, degenerative or revision surgery and NSAID use appeared to be independent predictor variables for the risk of SSI. The AUC was 0.72 (95% CI 0.65-0.79), indicating reasonable discriminative ability. CONCLUSIONS: We developed and internally validated a prediction model for SSI after instrumented thoracolumbar spine surgery using predictor variables of standard clinical practice that showed reasonable discriminative ability and calibration. Identification of patients at risk for SSI allows for individualized patient risk assessment with better patient-specific counseling and may accelerate the implementation of multi-disciplinary strategies for reduction of SSI. These slides can be retrieved under Electronic Supplementary Material.

Pain and disability after first-time spinal fusion for lumbar degenerative disorders: a systematic review and meta-analysis.

PURPOSE: Lumbar spinal fusion (LSF) is frequently and increasingly used in lumbar degenerative disorders despite conflicting results and recommendations. A thorough understanding of patient outcomes after LSF is required to inform decisions regarding surgery and to improve post-surgery management. The current study aims to evaluate the course of pain and disability in patients with degenerative disorders of the lumbar spine after first-time LSF. METHODS: A systematic review and meta-analysis of pain and disability outcomes in prospective cohort studies up to 31 March 2017 is identified in four electronic databases. Two independent researchers determined study eligibility, extracted data, and assessed risk of bias (modified Quality in Prognostics tool). A random effects model (maximum likelihood) was used to calculate means and 95% confidence intervals. The primary analysis was performed on complete data, and a sensitivity analysis was performed on all data. RESULTS: Twenty-five studies (n = 1777 participants) were included. The mean (95% confidence interval) Visual Analogue Scale (VAS) back pain (n = 9 studies) decreased from 64 (57-71) pre-surgery to 20 (16-24) at 24-month follow-up. Leg pain (n = 9 studies) improved from VAS 70 (65-74) pre-surgery to 17 (12-23) at 24-month interval. Disability (n = 12 studies), measured with the Oswestry Disability Index, decreased from 44.8 (40.1-49.4) pre-surgery to 17.3 (11.9-22.8) at 24-month follow-up. The sensitivity analysis yielded similar results. CONCLUSION: There is a substantial improvement in pain and disability after first-time LSF for degenerative disorders. However, long-term outcomes indicate that leg pain might be more reduced and for a longer period of time than axial back pain and disability. Registration PROSPERO CRD42015026922. These slides can be retrieved under Electronic Supplementary Material.

The diagnostic accuracy of imaging modalities to detect pseudarthrosis after spinal fusion-a systematic review and meta-analysis of the literature.

OBJECTIVE: The aim of the study was to determine the diagnostic accuracy of imaging modalities to detect pseudarthrosis after thoracolumbar spinal fusion, with surgical exploration as reference standard. MATERIALS AND METHODS: A systematic literature search for original studies was performed on the diagnostic accuracy of imaging as index test compared to surgical exploration as reference standard to diagnose pseudarthrosis after thoracolumbar spinal fusion. Diagnostic accuracy values were extracted and methodologic quality of studies was evaluated by the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Per modality, clinically comparable studies were included in subgroup meta-analysis and weighted odds ratios (ORs) were calculated using the random effects model. RESULTS: Fifteen studies were included. Risk of bias was classified as high/unclear in 58% of the studies. Concerns of applicability was classified as high/unclear in 40% of the studies. Four scintigraphy studies including 93 patients in total were pooled to OR = 2.91 (95% confidence interval [CI]: 0.93-9.13). Five studies on plain radiography with 398 patients in total were pooled into OR = 7.07 (95% CI: 2.97-16.86). Two studies evaluating flexion-extension radiography of 75 patients in total were pooled into OR = 4.00 (95% CI: 0.15-105.96). Two studies of 68 patients in total were pooled for CT and yielded OR = 17.02 (95% CI: 6.42-45.10). A single study reporting on polytomography, OR = 10.15 (95% CI 5.49-18.78), was also considered to be an accurate study. CONCLUSIONS: With a pooled OR of 17.02, CT can be considered the most accurate imaging modality for the detection of pseudarthrosis after thoracolumbar spinal fusion from this review.